Preview

Regulatory Research and Medicine Evaluation

Advanced search

Determination of Arbutin in Herbal Medicinal Products

https://doi.org/10.30895/1991-2919-2021-11-2-121-129

Abstract

Arbutin is the main active ingredient in many herbal medicinal products that have diuretic, antimicrobial, bactericidal, and antioxidant effects. Many of these products are mixtures of different herbal substances. Therefore, the approaches to quality control of HMPs can vary significantly.

The aim of the study was to compare arbutin assay procedures used in quality control of arbutin-containing products.

Materials and methods. Samples of the following HMPs were used in the study: monocomponent Bearberry Leaf and multicomponent Brusniver® (herbal mixture, powder). The test methods used were titrimetry, ultraviolet-visible spectrophotometry, and high-performance liquid chromatography (HPLC).

Results. The authors compared five arbutin assay procedures described in the monographs and product files for arbutin-containing HMPs.

Conclusions. It has been established that the analysed procedures cannot be used interchangeably as equivalent test methods; the limits for arbutin have to be established for each specific procedure. Iodometric titration is the most labour- and time-consuming method, and the determined titration endpoint is a subjective assessment. Spectrophotometric methods do not require the use of an arbutin reference standard, but they can give overestimated results as compared to the HPLC and titrimetry methods. HPLC methods are more selective, but they require the use of reference standards. The recommended test methods for HMP quality control are HPLC and visible spectrophotometry; the titrimetric method is recommended for replacement.

About the Authors

N. P. Antonova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Natalia P. Antonova, Сand. Sci. (Biol.)

8/2 Petrovsky Blvd, Moscow 127051, Russian Federation



S. S. Prokhvatilova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Svetlana S. Prokhvatilova, Сand. Sci. (Pharm.)

8/2 Petrovsky Blvd, Moscow 127051, Russian Federation



E. P. Shefer
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Elena P. Shefer, Сand. Sci. (Pharm.)

8/2 Petrovsky Blvd, Moscow 127051, Russian Federation



A. M. Kalinin
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Artem M. Kalinin

8/2 Petrovsky Blvd, Moscow 127051, Russian Federation



I. M. Morgunov
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Igor M. Morgunov

8/2 Petrovsky Blvd, Moscow 127051, Russian Federation



T. A. Golomazova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Tatiana A. Golomazova

8/2 Petrovsky Blvd, Moscow 127051, Russian Federation



U. S. Legon’kova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Uliana S. Legon’kova

8/2 Petrovsky Blvd, Moscow 127051, Russian Federation



References

1. Voloboy NL, Smirnov IV, Bondarev AA. Features of diuretic activity of arbutin and hydrochinone. Sibirskiy meditsinskiy zhurnal = Siberian Medical Journal. 2012;27(3):131–4 (In Russ.)

2. Brukhanov VM, Smirnov IV, Bondarev AA, Talalaeva OS, Shabanova VM, Zverev YaF, Udut VV. Arbutin’s and hydroquinone’s influence on free radical oxidation in rats blood. Biomeditsina = Biomedicine. 2011;1(1):41–9 (In Russ.)

3. Voloboy NL, Butakova LYu, Smirnov IV. Study of antimicrobial arbutin and hydroquinone in certain gram-flora of representatives. Khimiya rastitel’nogo syr’ya = Chemistry of Plant Raw Materials. 2013;(1):179–82 (In Russ.)

4. Hori I, Nihei K, Kubo I. Structural criteria for depigmenting mechanism of arbutin. Phytother Res. 2004;18(6):475–9. https://doi.org/10.1002/ptr.1456

5. Nikulin AV, Okuneva MV, Goryainov SV, Potanina OG. Development and validation of an HPLC-UV method for arbutin determination in bearberry leaves. Pharmaceutical Chemistry Journal. 2019;53(8):736–40. https://doi.org/10.1007/s11094-019-02071-3

6. Fedoseeva LM. Arbutin determination in underground and herbal parts of Bergenia crassifolia (L.) Fitsch, growing in Altai. Khimiya rastitel’nogo syr’ya = Chemistry of Plant Raw Materials. 2003;(1):73–7 (In Russ.)

7. Fursa NS, Onegin SV. Arbutin levels in the ling (Calluna vulgaris). Farmatsiya = Pharmacy. 2007;(6):12–4 (In Russ.)


Supplementary files

Review

For citations:


Antonova N.P., Prokhvatilova S.S., Shefer E.P., Kalinin A.M., Morgunov I.M., Golomazova T.A., Legon’kova U.S. Determination of Arbutin in Herbal Medicinal Products. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2021;11(2):121-129. (In Russ.) https://doi.org/10.30895/1991-2919-2021-11-2-121-129

Views: 1278


Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.


ISSN 3034-3062 (Print)
ISSN 3034-3453 (Online)